Adverse event reports for mefloquine hydrochloride ('Lariam') between 1980 ans 2018

Jane Quinn made this Freedom of Information request to Therapeutic Goods Administration

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The request was successful.

Dear Therapeutic Goods Administration,

The DAEN database identifies 240 adverse event reports lodged for the antimalarial drug mefloquine hydrochloride, also known by the trade name 'Lariam' lodged between 1 January 1980 and 17 February 2018.

The search engine, whilst producing a table of adverse event results for this drug, does not provide more detailed information on the date of event or co-reporting of categories of adverse reactions by submission.

Please could you provide me with a detailed list of all adverse events reported for this medication, including date, age of subject and list of adverse event categories selected.

I do not require any personal information or individual patient identifiers.

I look forward to your timely response to this request.

Yours faithfully,

Dr Jane Quinn

TGA FOI, Therapeutic Goods Administration

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Dear Dr Quinn

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Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

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[3]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

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Dear TGA FOI,

I have paid the fee by direct deposit on 19/06/2018 and emailed the address in your letter to confirm this accordingly.

I look forward to receiving the information requested in this FOI in due course.

Yours sincerely,

Jane Quinn

TGA FOI, Therapeutic Goods Administration

Dear Dr Quinn,

Thank you for your email.

As notified in the Estimate of Charges (Charges) dated 15 June 2018, the processing timeframe was suspended under section 31(2)(a) between the time the Charges was issues and the deposit was paid.

Accordingly, a decision is currently due on or before 17 July 2018.

If you have any questions, please do not hesitate to contact the FOI Team.

Kind regards,

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

-----Original Message-----
From: Jane Quinn [mailto:[FOI #4643 email]]
Sent: Tuesday, 19 June 2018 2:26 PM
To: TGA FOI
Subject: Re: FOI 361-1718 - Notice of Estimate of Charges [SEC=UNCLASSIFIED]

Dear TGA FOI,

I have paid the fee by direct deposit on 19/06/2018 and emailed the address in your letter to confirm this accordingly.

I look forward to receiving the information requested in this FOI in due course.

Yours sincerely,

Jane Quinn

-----Original Message-----

Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

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"Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information. If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author immediately and delete all copies of this transmission."

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TGA FOI, Therapeutic Goods Administration

6 Attachments

Dear Dr Quinn

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you receive
this transmission in error please notify the author immediately and delete
all copies of this transmission."

References

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